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Oral Protein / Peptide-based Drugs: Addressing Key Unmet Needs Across Disease Indications

Roots Analysis

Orally administrable protein / peptide-based therapeutics offer several advantages including, effective treatment of numerous clinical conditions and degenerative disorders. Pipeline Overview of Oral Peptide and Protein-based Therapeutics. Oral Protein / Peptide-based Drugs. Oral Protein / Peptide-based Drugs.

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China’s NMPA approves BeiGene’s Brukinsa to treat WM, CLL/ SLL

Pharmaceutical Technology

The small molecule Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa has been specially designed for delivering sustained BTK protein inhibition by optimising bioavailability, half-life, and selectivity.

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BeiGene’s Brukinsa receives UK marketing authorisations to treat cancers

Pharmaceutical Technology

Brukinsa is a small-molecule Bruton’s tyrosine kinase (BTK) inhibitor specially designed for delivering sustained and targeted BTK protein inhibition by optimising bioavailability, half-life, and selectivity. The regulatory approval for the BTK inhibitor to treat CLL was based on Phase III SEQUOIA and ALPINE clinical trials.

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EC approves BeiGene’s chronic lymphocytic leukaemia therapy

Pharmaceutical Technology

It was specifically designed to provide targeted and sustained BTK protein inhibition by optimising bioavailability, selectivity, and half-life. Currently, Brukinsa is being assessed in a broad clinical programme as monotherapy and along with other therapies for the treatment of several B-cell malignancies.

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PROTACs show promise for cancer treatment

Pharmaceutical Technology

Development of PROTACs (PROteolysis TArgeting Chimeras) has advanced fairly rapidly as excitement grows over their potential to selectively degrade proteins that are involved in various diseases, including cancer. PROTACs are a type of heterobifunctional degrader that offers multiple advantages over traditional small molecules.

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The Power of Lipids: Enhancing Drug Delivery with Nanoparticles

Roots Analysis

In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the main causes of drug failure in obtaining approval authorization.

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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably. The micronized capsule was progressed to Part 2 of the study and showed a linear increase in exposure (AUC) up to 800 mg, establishing safety margins for future clinical testing.